Varenicline In-Patient Study

NCT01413516 | Completed Phase 2 Results DMC

• 1 other identifier: VIP
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).

Conditions

Smoking Cessation

Keywords

Varenicline; Placebo; Inpatient

Outcome Measures

Primary Outcomes (1)

• 7 Day Point Prevalence Abstinence From All Forms of Tobacco

  Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.

  4 weeks after beginning study

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Smoking cessation counseling with placebo comparator

Behavioral: Smoking cessation counseling; Drug: Placebo

Experimental: Varenicline

ACTIVE COMPARATOR

Smoking cessation counseling with varenicline

Behavioral: Smoking cessation counseling; Drug: Varenicline

Interventions

Smoking cessation counseling BEHAVIORAL

Counseling sessions provided by a trained smoking counselor

Experimental: Varenicline; Placebo Control

Placebo DRUG

Sugar pill without any active medication

Also known as: sugar pill (control)

Placebo Control

Varenicline DRUG

Varenicline (an approved medication for smoking cessation)

Also known as: Chantix

Experimental: Varenicline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.

Sponsors & Collaborators

• Stanford University: lead
• Pfizer: collaborator

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Sugars; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Carbohydrates; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Judith Prochaska
• Organization: Stanford University

jodi.prochaska@stanford.edu

6507243608

Study Officials

• Judith J Prochaska, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 10, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 14, 2023
• Results First Posted: December 30, 2016

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)